Genetic Predisposition to Severe Forms of COVID-19 (SARS-CoV2 Infection) (COVIDGEN)
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ClinicalTrials.gov Identifier: NCT04644146 |
Recruitment Status : Unknown
Verified November 2020 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
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Condition or disease | Intervention/treatment |
---|---|
Covid19 | Genetic: GENETIC |
Study Type : | Observational |
Estimated Enrollment : | 40 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Genetic Predisposition to Severe Forms of COVID-19 (SARS-CoV2 Infection) in Patients Without Comorbidities |
Estimated Study Start Date : | December 1, 2020 |
Estimated Primary Completion Date : | June 1, 2021 |
Estimated Study Completion Date : | December 1, 2021 |
Group/Cohort | Intervention/treatment |
---|---|
SEVERE
Patients affected by SARS-CoV2 infection with severe lung dysfunction needing oxygen complementation and critical care supports - criteria 18-70yr old and without any comorbidities
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Genetic: GENETIC
It is a retrospective study on patients which has been hospitalized since the beginning of the COVID-19 pandemic in Lyon (march 2020). The blood samples have been collected I the frame of the regular follow-up of the patients and DNA extracted and conserved for the various research protocols ongoing in the University Hospital. The DNA will be analyzed by next generation sequencing |
CONTROL
Patients affected by SARS-CoV2, as shown by PCR and/or antigen testing diagnosis and without any or minor clinical expression
|
Genetic: GENETIC
It is a retrospective study on patients which has been hospitalized since the beginning of the COVID-19 pandemic in Lyon (march 2020). The blood samples have been collected I the frame of the regular follow-up of the patients and DNA extracted and conserved for the various research protocols ongoing in the University Hospital. The DNA will be analyzed by next generation sequencing |
- Primary criteria of data evaluation [ Time Frame: through study completion, average 6 months ]Number of genes affected by pathogenic variants in the SEVERE GROUP and for which no mutations have been observed in the CONTROL group For each gene sharing variants in the SEVERE GROUP and not in CONTROLS, the protein encoded by this gene will be identified and his function analyzed in the frame of various protein network software. The frequency of each mutation, so called the minor allele frequency will be evaluated in order to highlight only those which are rare (MAF < 0,01) in the normal population and thus suggesting a putative pathogenic role in the response to SARS-CoV2 infection.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients affected by COVID-10 Age: 18-70 (values included) Without any co morbidities (analysis of the clinical files in our hospital) Without any regular treatments
Exclusion Criteria:
- below 18yr and higher than 70yr old
- With comorbidities - ex: diabetes, obesity, hypertension, ischemic heart, neurological disorders, autoinflammatory / autoimmune diseases …
- Not agreeing the protocol (absence of informed consent)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644146
Contact: Alain CALENDER, MD | 0033 4 27 85 66 13 | alain.calender@chu-lyon.fr |
France | |
University Hospital LYON (Hospices Civils de LYON) | Recruiting |
Lyon, France, 69003 |
Responsible Party: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT04644146 |
Other Study ID Numbers: |
69HCL20_1072 |
First Posted: | November 25, 2020 Key Record Dates |
Last Update Posted: | November 25, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus SARS CoV2 COVID-19 genetics predisposition critical care |
COVID-19 Disease Susceptibility Genetic Predisposition to Disease Infections Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Disease Attributes Pathologic Processes |